SimulStat's Client

Long-Term, 100% Remote Contract- Sr.
CDISC ADaM Data Standards Consultant Responsibilities: Lead the development of ADaM data standards Provide strategic direction in the adoption and implementation of CDISC ADaM standards with appropriate level of documentation Develop and maintain Data Element Standard (DES) content and ADaM Implementation Guidance and documentation Author/Maintain developed ADaM Implementation Guides and implementation examples and update metadata repository Ensure that decisions with respect to ADaM implementation are ADaM-compliant and are in line with industry guidance Maintain current knowledge of all FDA, PMDA or other regulatory agency submission requirements and guidance documents pertaining to analysis datasets, metadata and versions accepted Provide input to continuously improve the management of ADaM standards and metadata Lead a collaborative team of subject matter experts with representation from all TAs Provide a single and consistent adoption and implementation of ADaM standards Provide training of implementation of ADaM Provide advice on how new and ongoing projects within orginization might best begin to use ADaM standards and how/when existing projects might need to up-version Review all changes and additions to SDTM standards due to maintenance or new CDISC versions to ensure that all ADaM input derivations and content based on SDTM are complete, correct and up to date Act as a point of contact to study teams and provide advice as needed on ADaM implementation Review study level ADaM dataset specifications Attend study team meetings Discuss and resolve compliance issues including the dispositioning of Pinnacle 21 issues Interface with statistical programming groups developing automation for define.xml, analysis dataset and TFL production Ensure standard DDTs are kept up to date with GSP standard template and evolving define.xml requirements Ensure that analysis standards can be applied broadly When requested, participate in internal meetings Provide expert opinion on difficult ADaM implementation issues Explain ADaM concepts and reasons why a certain implementation approach is preferred Represent organization on the CDISC ADaM team Key Skills / Knowledge: In depth knowledge/experience of data collection and reporting in drug development and clinical trials processes Experience with a variety of study designs, TA's, and analysis methods Experience of implementing ADaM data standards in a practical setting ADaM-IG v1.1 and v1.0 practical knowledge ADaM metadata practical knowledge Solid knowledge of SDTM and CDISC TAUGs Solid knowledge of define.xml Aptitude for data standards and data standardization Excellent verbal and written communication skills A general understanding of the metadata requirements for analysis results and for ADaM datasets Collaborating in global cross-functional teams Knowledge of project management, documentation writing, training, and compliance Use of software and data applications within drug development Knowledge of computer programming, preferably SAS or other procedural languages Appreciation of computer system architecture and hardware Qualifications: Basic Qualifications Bachelor's degree or equivalent in statistics/ biostatistics, programming, life science, computer science, business administration or related discipline or equivalent combination of education and experience. 8+ years knowledge/experience in Pharmaceutical / Biotech industry Demonstrated effective communication skills (written and oral) Preferred Qualifications Master's degree or equivalent in statistics/ biostatistics, programming, life science, computer science, business administration or related discipline 10 years' work experience in data management, biostatistics or programming in the Pharmaceutical or Biotech arena 3+ years' experience in a global organization Demonstrated ability to influence decision making Development of policies and SOPs

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